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FDA 510(k)

OMIBAND

K-Number: K904445 · 1991-03-06

ApplicantOmikron Scientific, Ltd.
Decision Date1991-03-06
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMIBAND is the device name listed in this FDA 510(k) record. The listed applicant is Omikron Scientific, Ltd.. It received FDA 510(k) clearance on 1991-03-06 under 510(k) number K904445. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMIBAND?

OMIBAND is a medical device that received FDA 510(k) clearance on 1991-03-06. The listed applicant is Omikron Scientific, Ltd.. The 510(k) number is K904445.

When did OMIBAND receive FDA 510(k) clearance?

OMIBAND received FDA 510(k) clearance on 1991-03-06, under 510(k) number K904445.

Who is the listed applicant for OMIBAND?

The FDA 510(k) record lists Omikron Scientific, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMIBAND?

The FDA product code for OMIBAND is KGX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omikron Scientific, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K874480MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)K844277OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLARK840748LITHIUM PACEMAKER 811-811L & 811XL

Related Devices (Code: KGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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